Postoperative Hypersensitivity Randomized Comparative Effectiveness Research Trial
- Conditions
- Dental Caries
- Interventions
- Procedure: Restoration with a dentin bonding agent (DBA)Procedure: Restoration with a resin modified glass ionomer liner (RMGI)
- Registration Number
- NCT01268605
- Lead Sponsor
- Pearl Network
- Brief Summary
Postoperative hypersensitivity (POH) is a problem for many patients as determined by the recent Practitioners Engaged in Applied Research and Learning (PEARL) study of POH following occlusal caries restoration. The objectives of this two-armed randomized comparative effectiveness research trial (RCERT) are to determine whether adding a resin modified glass ionomer liner (RMGI) reduces POH in dentin bonded Class I resin based composite (RBC) restorations, and to identify other factors (putative risk factors) that are associated with increased POH.
The primary outcome of this study is the reduction/elimination of restoration POH as measured by clinical assessment (air stream) and patient-reports.
Outcomes will be ascertained via the following specific aims:
Specific Aim 1: To compare the reduction of hypersensitivity of study teeth by clinical measurement (air drying) and by patient-reported outcomes among the two treatment groups at three points in time: prior to restoration and at one and four weeks postrestoration.
Specific Aim 2: To identify putative risk factors for POH (or factors associated with differences in POH) including: preoperative caries stage measured by the proposed American Dental Association (ADA) Caries Classification System (CCS), lesion depth as measured on the preoperative radiograph, dentin caries activity ranked on opening the lesion, preparation depth, and patient sleep bruxism status.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 341
- Presence of solely adult dentition ages 15 to 60 (The upper age of 60 years is selected since the pulp space is limited and POH is less likely above this age).
- Presence of one or more permanent posterior teeth (in different quadrants, with third molars excluded) with the clinical diagnosis of new Class I caries extending into dentin with or without radiographic confirmation. Up to 4 teeth (one per quadrant) may be enrolled. If there is more than one occlusal lesion in a quadrant that meets the inclusion criteria the patient is not eligible for inclusion in the study. Only one tooth per quadrant can be treated during the 4 weeks of this study.
- Lesion depth, if visible on radiograph, must be ≤1/2 the distance from the Dento-Enamel Junction (DEJ) to the pulp and the radiograph cannot be more than 9 months old.
- The tooth must be in occlusion with a natural tooth.
- A resin-based composite restoration would be the standard of care for the lesion.
- The tooth must be free of evidence of a pulpitis (no report of lingering pain associated with any stimulus).
- Subjects must be available for contact for at least four weeks post-treatment.
- Subjects willing and able to understand and sign the IRB-approved informed consent form and for individuals under the age of 18, the parental / guardian assent form.
- Subject's baseline score on the NPAS must be ≥3 for air and/or cold stimulation but not exhibit pain lasting more than approximately four seconds which is known as "lingering pain"
- Gingival Index of less than or equal to 2.
- Individuals in which the second molars are not fully erupted.
- Teeth with a mobility of 2 or greater, or inflamed gingival tissues.
- Existing restoration(s) on the same tooth.
- Teeth that have been clinically assessed to be fractured.
- Tooth is an abutment for a removable partial denture.
- Tooth with subgingival calculus, unless removed during the treatment visit.
- Subjects undergoing active orthodontic treatment. Use of retainers is allowed.
- Subjects currently enrolled in or who have completed in the past month a tooth bleaching program.
- Subjects with prior reaction or inability to tolerate any of the dental products being used, such as severe topical or hypersensitivity reaction.
- Subjects under treatment for medical disorders including: dementia, Parkinson's disease, severe depression, severe anxiety, and any other medical condition that, in the opinion of the P-I, would affect the subject's judgment of postoperative hypersensitivity and ability to understand the informed consent process.
- Subjects in another ongoing dental research study.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Restoration with a dentin bonding agent (DBA) Restoration with a dentin bonding agent (DBA) Restoration with a dentin bonding agent (DBA) and hybrid resin-based composite: Use of a self-etch DBA Clearfil SE Bond followed by Herculite Ultra resin-based composite (Sybron/Kerr), comprising a state-of-the-art bonding and restoration system for cervical lesions. Restoration with a resin modified glass ionomer liner (RMGI) Restoration with a resin modified glass ionomer liner (RMGI) Restoration with a resin modified glass ionomer liner (RMGI) (Vitrebond LC, placed on the pulpal floor at a thickness of approximately 0.5 mm) followed by application of a two step self etch DBA and nanofilled resin based composite (RBC).
- Primary Outcome Measures
Name Time Method Hypersensitivity 4 weeks To compare the reduction of hypersensitivity of study teeth by clinical measurement (air drying) and by patient-reported outcomes among the two treatment groups at three points in time: prior to restoration and at one and four weeks postrestoration.
- Secondary Outcome Measures
Name Time Method Preparation depth Baseline To identify putative risk factors for POH (or factors associated with differences in POH) including: preoperative caries stage measured by the proposed ADA Caries Classification System (CCS), lesion depth as measured on the preoperative radiograph, dentin caries activity ranked on opening the lesion, preparation depth, and patient sleep bruxism status.
Preoperative caries stage Baseline To identify putative risk factors for POH (or factors associated with differences in POH) including: preoperative caries stage measured by the proposed ADA Caries Classification System (CCS), lesion depth as measured on the preoperative radiograph, dentin caries activity ranked on opening the lesion, preparation depth, and patient sleep bruxism status.
Lesion depth Baseline To identify putative risk factors for POH (or factors associated with differences in POH) including: preoperative caries stage measured by the proposed ADA Caries Classification System (CCS), lesion depth as measured on the preoperative radiograph, dentin caries activity ranked on opening the lesion, preparation depth, and patient sleep bruxism status.
Dentin caries activity Baseline To identify putative risk factors for POH (or factors associated with differences in POH) including: preoperative caries stage measured by the proposed ADA Caries Classification System (CCS), lesion depth as measured on the preoperative radiograph, dentin caries activity ranked on opening the lesion, preparation depth, and patient sleep bruxism status.
Sleep bruxism status Baseline To identify putative risk factors for POH (or factors associated with differences in POH) including: preoperative caries stage measured by the proposed ADA Caries Classification System (CCS), lesion depth as measured on the preoperative radiograph, dentin caries activity ranked on opening the lesion, preparation depth, and patient sleep bruxism status.
Trial Locations
- Locations (41)
Peggy Richardson, DDS, MS
🇺🇸Tinley Park, Illinois, United States
Bay Dental PC
🇺🇸Brooklyn, New York, United States
Dr. Howard Spielman
🇺🇸Plainsboro, New Jersey, United States
Eric Leibowitz DDS
🇺🇸Brooklyn, New York, United States
Complete Dental Arts, P.C.
🇺🇸Newnan, Georgia, United States
James R. Keenan, DDS, PC
🇺🇸Rockaway Beach, New York, United States
Jana A. Ikeda, DDS, PC
🇺🇸Boulder, Colorado, United States
Janice K. Pliszczak, DDS
🇺🇸Syracuse, New York, United States
Laurence H Stone, DDS
🇺🇸Doylestown, Pennsylvania, United States
Maryann Lehmann, D.D.S.
🇺🇸Darien, Connecticut, United States
Phoenix Pediatric Dental
🇺🇸Phoeniz, Arizona, United States
Corridor Kids Pediatric Dentistry
🇺🇸North Liberty, Iowa, United States
Minnesota Dentalcare
🇺🇸Richfield, Minnesota, United States
Bordentown Family Dental
🇺🇸Bordentown, New Jersey, United States
Small Smiles Dental Center of Springfield, LLC
🇺🇸Springfield, Massachusetts, United States
Frank A Dahlstrom,DMD,PC
🇺🇸Dennis, Massachusetts, United States
Keith A Hudson DDS PC
🇺🇸Franklin, Michigan, United States
Dr. Julie Ann Barna
🇺🇸Lewisburg, Pennsylvania, United States
Cheryl F, Callahan, DDS, PA
🇺🇸Rockville, Maryland, United States
Oracare Research
🇺🇸Sanford, Florida, United States
Creative Smiles Dental Care
🇺🇸Champaign, Illinois, United States
Queens Comprehensive Dental Services
🇺🇸Forest Hills, New York, United States
Dr. Jeannette Abboud-Niemczyk
🇺🇸Drexel Hill, Pennsylvania, United States
Elizabeth W. Galloway
🇺🇸Hilton Head Island, South Carolina, United States
MEHOP
🇺🇸Bay City, Texas, United States
Gilberto Nunez DDS LLC
🇺🇸Kingston, New York, United States
Scott B Schaffer, DMD
🇺🇸Clark, New Jersey, United States
Allan J Horowitz, DMD
🇺🇸King of Prussia, Pennsylvania, United States
Salvation Army Dental Center
🇺🇸Oil City, Pennsylvania, United States
Oral Health Center
🇺🇸Southborough, Massachusetts, United States
Watson and Niven Dental Partnership
🇺🇸Newport Beach, California, United States
Oral Medicine - Tufts School of Dental Medicine
🇺🇸Boston, Massachusetts, United States
Cynthia Jetter, DMD
🇺🇸Voorhees, New Jersey, United States
Susan D. Bernstein, DDS
🇺🇸Cincinnati, Ohio, United States
Gentle Dental Care, LLC
🇺🇸Edison, New Jersey, United States
East Avenue Dentistry PLLC
🇺🇸Rochester, New York, United States
Kokomo Oral Implantology
🇺🇸Kokomo, Indiana, United States
Community Dental - Biddeford Center
🇺🇸Biddeford, Maine, United States
Barry G. Dale, DMD
🇺🇸Tenafly, New Jersey, United States
Eric Hirschfeld, D.D.S.
🇺🇸Conway, New Hampshire, United States
Kay T. Oen, DDS
🇺🇸Port Chester, New York, United States